Health Advocate Support for Liver Transplant Complications

(HEAL-Tx Pilot Trial)

Overseen By Sharad Wadhwani, MD, MPH

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, San Francisco

Disqualifiers: Non-English, Non-US residents, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The Health Advocate for Liver Transplant (HEAL-Tx) Pilot is a nonrandomized, open-label intervention pilot of a health advocate intervention aimed to assess feasibility and acceptability of integrating a Health Advocate onto the transplant team. Across studies, health advocate roles vary, and can include coordinating medical care treatment, facilitating financial assistance (e.g., taxi vouchers), and connecting patients to community resources, which can improve self-management, mitigate social risks, and lead to better communication between the healthcare system and the family. In this pilot, the investigators will adapt this intervention for pediatric liver transplant patients and measure acceptability and feasibility according to RE-AIM.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the treatment Health Advocate, Health Advocate, Patient Navigator, Care Coordinator for liver transplant complications?

Research shows that having a nursing coordinator or advocate involved in liver transplant care can improve patient support and education, which helps manage complications and improve quality of life after the transplant. ^{1 2 3 4 5}

Is the Health Advocate Support for Liver Transplant Complications treatment safe for humans?

The research articles reviewed do not provide specific safety data for Health Advocate Support or similar roles like Patient Navigator or Care Coordinator in the context of liver transplant complications or other conditions. ^{6 7 8 9 10}

How is the Health Advocate treatment different from other treatments for liver transplant complications?

The Health Advocate treatment is unique because it focuses on providing personalized support and guidance to patients, helping them navigate the complex healthcare system and manage their post-transplant care, unlike traditional treatments that primarily involve medications and medical procedures. ^{1 3 11 12 13}

Research Team

Sharad Wadhwani, MD, MPH

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for children under 18 who have had a liver transplant. They and/or their guardians must understand English or Spanish, agree to the study's terms, and be chosen by the transplant team as suitable participants. It excludes adults, non-English/Spanish speakers, those unwilling to complete surveys, wards of the state, and non-US residents.

Inclusion Criteria

I am under 18 and have had a liver transplant.

Subject and/or parent/legal guardian can provide written informed consent and willing to comply with study procedures

Subject and/or parent/legal guardian is willing to be contacted in the future by study staff

Exclusion Criteria

I do not speak English or Spanish.

Child is a ward of the state (e.g. foster care) since present circumstances may not be reflective of child's past or future circumstances

I am over 18 years old.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Health Advocate intervention aimed at improving self-management and communication with the healthcare system

90 days

Regular interactions with Health Advocate

Follow-up

Participants are monitored for changes in caregiver experience and medication adherence

90 days

In-depth interviews and surveys

Extended Follow-up

Assessment of medication adherence 6 months after study entry

180 days

Treatment Details

Interventions

• Health Advocate (Behavioral Intervention)

Trial Overview The HEAL-Tx Pilot tests if adding a Health Advocate to the pediatric liver transplant team helps with care coordination, financial support like taxi vouchers, and linking families to community resources. The goal is to see if this improves self-care and communication between families and healthcare providers.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

This is a single arm pilot intervention.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

A quality improvement project at an academic medical center aimed to enhance the inpatient experience for living liver donors by developing nursing standards and procedures for consistent care during their hospital stay.

The introduction of Designated Donor Nurses, who act as advocates and resources for live liver donors, is proposed to ensure specialized care and support, addressing the challenge of having all nursing staff be experts in donor care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality improvement in the care of live liver donors: implementation of the Designated Donor Nurse Program. LaPointe Rudow, D., Cabello, CC., Rivellini, D.[2022]

Effective post-operative care is crucial for patients after liver transplantation, emphasizing the need for immediate support and monitoring to ensure successful recovery.

The role of the transplant coordinator is vital in providing education and long-term follow-up, which helps improve health outcomes and quality of life for liver transplant recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Care of patients following liver transplantation. Fullwood, D., Jones, F., Lau-Walker, M.[2016]

Liver transplantation is the only definitive treatment for end-stage liver disease, with about 15% of recipients in the U.S. being 65 or older, highlighting the importance of careful management in older patients.

Post-transplant complications such as infection and acute graft rejection can be minimized through strict adherence to follow-up care and medication management, emphasizing the critical role of nurses in educating patients and their support systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liver transplantation in older adults. Hansen, L.[2014]

The study followed 145 patients at Hadassah Medical Center before and after liver transplantation, providing insights into the medical and nursing care involved in the process.

The review highlights the importance of nursing coordinators in managing liver transplantation, addressing factors like liver disease causes, drug side effects, complications, and patient survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liver transplantation and nursing care in Israel. Rowe, M., Safadi, R., Ashur, Y., et al.[2019]

The process of receiving a liver transplant involves a complex emotional journey for the patient, characterized by feelings of waiting, hope, fear, and survival.

Nurse-coordinators play a crucial role in supporting patients throughout this journey, helping them navigate the psychological challenges from diagnosis to the transplant procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A liver transplant, a specific temporal experience]. Sabar, I., Berthelot, G., Danet, C., et al.[2012]

Patients and their families often have concerns that can precede serious adverse events in healthcare, highlighting the importance of their input in clinical settings.

Empowering patients to actively participate in documenting their clinical history could lead to safer healthcare systems by ensuring their concerns are acknowledged and addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An audible patient voice: How can we ensure that patients are treated as partners in their own safety? Subbe, CP., Ahsan, S., Smith, L., et al.[2021]

A new tool for clinicians in inpatient oncology units has been developed to prevent adverse events and enhance patient safety, focusing specifically on cancer patients.

The tool includes a catalog of adverse events and a risk map, which helps healthcare providers implement best practices in their daily activities to improve clinical safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient safety in the inpatient setting through risk assessment and mitigation. Reche Navarro, MN.[2016]

A study analyzing 17,868 medical adverse event records from Maccabi Healthcare Community found that communication issues and inattentiveness were the most frequently reported problems by both physicians and nurses.

The research suggests implementing better information-sharing and feedback mechanisms to reduce preventable medical adverse events, highlighting the need for targeted quality improvement efforts in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined SNA and LDA methods to understand adverse medical events. Zhu, L., Reychav, I., McHaney, R., et al.[2020]

The failure to report potential deceased organ donors and issues during the procurement process can lead to longer wait times and higher mortality rates for patients on transplant lists, highlighting a significant societal impact.

Nurses play a crucial role in the organ procurement process, as their education and experience enable them to help identify risks and implement strategies to prevent errors, ensuring better outcomes for potential transplant candidates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of nurses in the risk management of organ and tissue donation. Saviozzi, A.[2010]

A symposium with 31 healthcare professionals highlighted that preventing adverse events in community care requires a multi-faceted approach involving policy changes at various levels, including system integration and improved communication among providers.

Key recommendations from the symposium include prioritizing education for clinicians and caregivers, enhancing organizational culture, and leveraging technology to improve patient safety and reduce adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in community care: implications for practice, policy and research. Masotti, P., Green, M., McColl, MA.[2019]

Liver transplantation is a viable treatment for end-stage liver disease, but there is a significant gap between the number of people waiting for transplants (16,377) and the number actually performed (6,492 in 2007), highlighting the need for better access and planning for potential recipients.

Post-transplant care is crucial to prevent complications such as graft dysfunction and infections, and requires a multidisciplinary approach, including the involvement of critical care nurses, to ensure successful long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical care management of the liver transplant recipient. Rudow, DL., Goldstein, MJ.[2008]

Nurses play a crucial role in the multidisciplinary care of liver transplant patients, particularly during critical phases of the transplant process, by being accountable for planning and evaluating patient care.

Effective communication by the transplant nurse is essential for coordinating care and supporting patients in achieving independence post-transplant through education on diet, medications, and monitoring health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of the nurse in the multidisciplinary team approach to care of liver transplant patients. Overman, JA., Cox, DL., Buchl, LL., et al.[2019]

A national survey of adult transplant hepatologists revealed that only 46.1% of young adult liver transplant recipients arrive at their first adult clinic with adequate knowledge of their condition and a parent or guardian, highlighting a significant gap in patient preparedness for transition.

Only 15.5% of hepatologists reported having a formal transition program, and those with such programs were less likely to see patient knowledge and adherence as barriers, suggesting that implementing structured transition strategies could enhance care for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National survey of adult transplant hepatologists on the pediatric-to-adult care transition after liver transplantation. Heldman, MR., Sohn, MW., Gordon, EJ., et al.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

Quality improvement in the care of live liver donors: implementation of the Designated Donor Nurse Program. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Care of patients following liver transplantation. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Liver transplantation in older adults. [2014]

4. United States pubmed.ncbi.nlm.nih.gov

Liver transplantation and nursing care in Israel. [2019]

5. France pubmed.ncbi.nlm.nih.gov

[A liver transplant, a specific temporal experience]. [2012]

6. England pubmed.ncbi.nlm.nih.gov

An audible patient voice: How can we ensure that patients are treated as partners in their own safety? [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Improving patient safety in the inpatient setting through risk assessment and mitigation. [2016]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Combined SNA and LDA methods to understand adverse medical events. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

The role of nurses in the risk management of organ and tissue donation. [2010]

10. Canada pubmed.ncbi.nlm.nih.gov

Adverse events in community care: implications for practice, policy and research. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Critical care management of the liver transplant recipient. [2008]

12. England pubmed.ncbi.nlm.nih.gov

Role of the nurse in the multidisciplinary team approach to care of liver transplant patients. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

National survey of adult transplant hepatologists on the pediatric-to-adult care transition after liver transplantation. [2015]